Hectronic is engaged in development, manufacturing and maintenance of embedded computers for use in medical applications. Defining requirements in this market includes quality assurance, certifications and product longevity. We meet the requirements ourselves and through close partnerships with manufacturers certified according to ISO 13485, the regulatory requirement for production of medical technology products.

The requirement for product longevity is partly explained by the certification process. It’s a costly and demanding process to certify products according to medical technology directives. To avoid having to go through that process more often than absolutely necessary one of the main priorities are product longevity.

Product longevity in focus

Hectronic offers both COTS products and full custom design embedded systems and boards for applications in medical technology. Our custom design projects are based on one of our own processor platforms which come in the shape of Computer-On-Modules (COM), in form factors like Qseven or COM Express to be mounted on tailor made carrier boards.

A form factor is an industry standard including specification of for example dimensions, hole patterns, power consumption and interfaces. This standardization makes it less complex to change from one COM to another COM of the same form factor.

Some of our custom design projects involve integrating the processor platform from a COM onto a fully customized computer board or system. Through the IP ownership, control over the selection of components, BIOS and drivers we have a unique possibility to extend product longevity, if that’s your requirement.

The embedded computers we develop for customers within medical technology typically don’t require adaptation to demanding environments. Temperatures, vibrations, dust and water are not a more of a challenge than in a well-kept office. There are exceptions to the rule of course such as part of or in close range to x-ray or radiation equipment.

Meeting regulatory requirements

Other requirements are stricter. Since at least some of the embedded computers are involved in diagnosis or treatment of patients so malfunction may be catastrophic. Requirements for reliability and quality are clear and unquestionable and are defined by the type of application and the geographical market. ISO 13485, EN 60601, FDA approval and CE marking according to the medical device directive are a couple of examples.

Apart from COTS products adapted to requirements from medical applications we have experience from developing custom design systems and single board computers.

If you are looking for more information or have an inquiry, do not hesitate to contact our sales department at +46 18 660 700 or send us an email to sales@hectronic.se.